Bioequivalence Study of Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-NC9AN58
Tanggal Input Registry : 18-08-2023

12-02-2022
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration) 1; 2; 3; 3,5; 4; 4,5; 5; 5,5; 6; 8; 10; 12; 16; 24; 36; 48; and 72 hours after drug administration (18 time points) after drug administration] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [[time points : 0 hours (before drug administration) 1; 2; 3; 3,5; 4; 4,5; 5; 5,5; 6; 8; 10; 12; 16; 24; 36; 48; and 72 hours after drug administration (18 time points) after drug administration] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia
Bioequivalence Study of Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia
Interventional
The reference drug was Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia, batch number 19020306, manufacturing date on March 2019, expired date on February 2022. The test drug was Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk, batch number FP09.E2004.021, manufacturing date May 2020, Expired date April 2022. In sampling day, subject took one dose of Meloxicam manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position.
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Inclusion Criteria:

Inclusion criteria in this study include: a. Sign informed consent b. Healthy, based on clinical laboratory tests (routine hematology, liver function, kidney function, blood sugar, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination; c. Male and female subjects (if female, consider the risk in women of childbearing age and take a pregnancy test); d. Age between 18 - 55 years; e. Body weight within the normal range according to Body Mass Index (BMI) 18 - 25 kg/m2; f. Vital signs were in the following range systolic blood pressure 110 - 129 mmHg, diastolic blood pressure 70 - 84 mmHg, pulse within the normal range 60 - 90 bpm, check oxygen saturation (SpO2) within the normal range 95-100%, and heart rate breathing within the normal range of 12-20/min;

Exclusion Criteria:

Exclusion criteria in this study include: a. Smoking more than 10 cigarettes per day; b. Pregnant or nursing women. A pregnancy test is carried out before screening and before administering the test drug or comparator; c. Have a history of kidney, liver disease, and have a history of allergies or hypersensitivity or contraindications to the bioequivalence test drug (Meloxicam); d. Clinically significant haematological abnormalities; e. Electrocardiogram (ECG) abnormalities; f. Difficulty in venous accessibility in the left or right arm; g. History of ongoing serious illness or chronic disease that is clinically or medically significant; h. History of drug or alcohol abuse in the 12 months (1 year) prior to screening for this study; i. Positive serological tests include Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); j. The test result of the SARS-CoV-2 antigen rapid test is positive (if the BE test is carried out during a pandemic); k. Have a history or condition that may affect the kinetics of the drug; l. Using drugs or food supplements no more than 7 days since the study began; m. Participated in a previous clinical trial no later than 3 months from the time the study started; n. Blood donation or blood loss of more than 200 ml less than 3 months from the start of the study.
 
KET-1019/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T